8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
RESUBMITTED RADIOAEROSOL CONT. SYSTEM MP-963
FDA 510(k)
FDA Class 2
·Anesthesiology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867050587·LO-PRO SCRW,TI,3.5MMX 32MM
CUTTERBOND ZINC PHOSPHATE CEMENT
FDA 510(k)
FDA Class 2
·Dental
LIAISON Anti-HAV Assay
FDA 510(k)
FDA Class 2
·Microbiology
TOTAL ASR FEM IMP SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·July 6, 2015
XPANDER IBT
FDA Adverse Event
Malfunction
·KYPHON NEUCHATEL·Product code HRX·January 2, 2013
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·February 14, 2014
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020